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FDA Identifies Review Issues For Spero's Tebipenem Application, Shares Plunge

·1 min read
  • Spero Therapeutics Inc (NASDAQ: SPRO) will defer current commercialization activities for tebipenem HBr based on feedback from a recent Late Cycle Meeting (LCM) with the FDA.

  • The discussion suggested that the data package may be insufficient to support approval during this review cycle.

  • In evaluating the efficacy of tebipenem HBr in Phase 3 (ADAPT-PO) cUTI study, the FDA conducted a separate analysis of the microbiological intent-to-treat (micro-ITT) population.

  • Also Read: FDA Lifts Clinical Hold On Spero Therapeutics' Lung Infection Program.

  • The effect of this new analysis was to reduce the number of evaluable patients in the primary analysis population compared with those resulting from the trial's pre-specified micro-ITT population as outlined in the statistical analysis plan.

  • Hence, the FDA considers that the pre-specified non-inferiority margin of -12.5% was not met.

  • With this development, Spero will reduce its workforce by approximately 75% to 35 from 146 full-time employees.

  • The company will incur approximately $8.0 million in severance costs.

  • Spero would prioritize advancing SPR720 and SPR206 to Phase 2 milestones, including key deliverables through 2024, while engaging with the FDA on the appropriate path forward for tebipenem HBr.

  • Spero ended 2021 with an estimated $146.4 million in cash. Based on the anticipated cost savings, the company anticipates a cash runway into late 2023.

  • Price Action: SPRO shares are down 61.30% at $1.97 on the last check Tuesday.

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